Table 2.
Adverse events
| AE, n (%) | Healthy volunteers | Participants with PD | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Placebo, n = 14 | BIIB054 | Placebo, n = 6 | BIIB054 | |||||||||
| All, n = 34 | 1 mg/kg, n = 3 | 5 mg/kg, n = 7 | 15 mg/kg, n = 6 | 45 mg/kg, n = 6 | 90 mg/kg, n = 6 | 135 mg/kg, n = 6 | All, n = 12 | 15 mg/kg, n = 6 | 45 mg/kg, n = 6 | |||
| Any AE | 7 (50) | 19 (56) | 1 (33) | 4 (57) | 2 (33) | 2 (33) | 5 (83) | 5 (83) | 6 (100) | 9 (75) | 5 (83) | 4 (67) |
| AEs in ≥10% in placebo or all BIIB054 | ||||||||||||
| Headache | 4 (29) | 8 (24) | 1 (33) | 2 (29) | 0 | 1 (17) | 3 (50) | 1 (17) | 2 (33) | 4 (33) | 2 (33) | 2 (33) |
| Dizziness | 2 (14) | 5 (15) | 1 (33) | 1 (14) | 0 | 1 (17) | 1 (17) | 1 (17) | 0 | 0 | 0 | 0 |
| Procedural pain | 1 (7) | 4 (12) | 0 | 1 (14) | 0 | 1 (17) | 1 (17) | 1 (17) | 0 | 0 | 0 | 0 |
| Back pain | 1 (7) | 2 (6) | 0 | 0 | 0 | 0 | 1 (17) | 0 | 0 | 2 (17) | 1 (17) | 1 (17) |
| Post–LP syndrome | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 (17) | 1 (17) | 1 (17) |
| Upper respiratory tract infection | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 (17) | 1 (17) | 1 (17) |
| CTCAE grade | ||||||||||||
| 2 | 1 (7)a | 5 (15)b | 1 (33)b | 0 | 1 (17) | 0 | 3 (50)b | 0 | 2 (33)c | 4 (33)d | 2 (33)d | 2 (33)d |
| 3 | 0 | 1 (3)e | 0 | 0 | 0 | 0 | 0 | 1 (17)e | 1 (17)f | 0 | 0 | 0 |
| AEs related to study treatment | 2 (14) | 4 (12)g | 0 | 0 | 1 (17) | 0 | 1 (17) | 2 (33)g | 1 (17)f | 1 (8) | 0 | 1 (17) |
| Serious AEs | 0 | 1 (3)e | 0 | 0 | 0 | 0 | 0 | 1 (17)e | 1 (17)f | 0 | 0 | 0 |
AE, adverse event; CTCAE, Common Terminology Criteria for Adverse Events; LP, lumbar puncture; PD, Parkinson's disease.
Foot fracture and pain.
One healthy volunteer who received BIIB054 1 mg/kg and 2 who received BIIB054 90 mg/kg experienced grade 2 headaches; 1 healthy volunteer who received BIIB054 15 mg/kg experienced a grade 2 episode of ventricular tachycardia while sleeping; and 1 healthy volunteer who received BIIB054 90 mg/kg experienced grade 2 dyspepsia.
One participant experienced a grade 2 headache, and 1 participant experienced a grade 2 ear infection.
One participant who received BIIB054 15 mg/kg had a grade 2 post–LP syndrome, and 1 participant who received BIIB054 15 mg/kg experienced a grade 2 headache and grade 2 constipation; 1 participant who received 45 mg/kg BIIB054 experienced a grade 2 bone contusion; and 1 participant who received BIIB054 45 mg/kg experienced 2 grade 2 headaches and grade 2 back pain.
Asymptomatic cerebrovascular accident considered related to study treatment.
Asthma exacerbation considered unrelated to study treatment.
One healthy volunteer who received BIIB054 135 mg/kg experienced a hypersensitivity reaction considered related to the study drug and discontinued study drug after administration of 163 mL (32%) of the 508‐mL infusion.